Acute Kidney DiseaseKARMANCT07052617
Impact of Different CRRT Modalities, Dosing Strategies, and Timing on Kidney Recovery and Prolonged Kidney Dysfunction
An observational study of Acute Kidney Disease and Acute Kidney Injury, run by Croatian Society for Organ Support.
Trial summary
KARMA study is a hospital-based research study looking at how different ways of delivering kidney support therapy (CRRT) affect patients who are critically ill. In some cases, the kidneys may temporarily stop working in very sick patients, and machines are used to filter the blood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Disease, Acute Kidney Injury
- What is being tested?
- Continuos renal replacement therapy
- Type of treatment
- Medical device
- How many people
- 2,500 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2025to 25 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: By analyzing the variation in therapeutic approaches across centers-including convection- and diffusion-based techniques, dose intensity, and initiation thresholds-KARMA study aims to identify best practices that promote renal recovery and reduce the transition to acute kidney disease. The study integrates clinical, biochemical, and outcome metrics to support a precision medicine framework in critical care nephrology and in critically ill patients with acute kidney injury.
Who may be able to join
- Acute kidney injury
- ICU administration
Who cannot join
- Pre-existing CKD (GFR < 30 ml/min/1,73m2)
- Chronic dialysis-dependent end-stage renal failure
About this study
Official title: A Multicentric Observational Study Examining How Different CRRT Modalities, Dosing Strategies, and Timing Impact Kidney Recovery and the Development of Prolonged Kidney Dysfunction (Acute Kidney Disease) in Critically Ill Patients
KARMA study is a hospital-based research study looking at how different ways of delivering kidney support therapy (CRRT) affect patients who are critically ill. In some cases, the kidneys may temporarily stop working in very sick patients, and machines are used to filter the blood. This study is exploring whether the way the investigators use these machines - how early to start, how much treatment to give, and what type to choose - makes a difference in how well the kidneys recover. By learning from many hospitals and hundreds of patients, KARMA hopes to improve treatment choices and help patients regain their kidney function faster.
- Conditions
- Acute Kidney Disease, Acute Kidney Injury
- Being tested
- Continuos renal replacement therapy
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuos renal replacement therapyDevice
Different modalities of CRRT: continuous veno-venous hemofiltration; continuous veno-venous hemodialysis and continuous veno-venous hemodiafiltration Different doses of CRRT: low effluent dose (<15 ml/kg/h); medium-low effluent dose (15-25 ml/kg/h); standard effluent dose (25-30 ml/kg/h); high effluent dose (>30 ml/kg/h
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with AKD
Percentage of patients with AKD divided by subgroups regarding AKI etiology
Measured: 90 days
Secondary outcomes (1)
Durations and severity of AKD, free days of CRRT and kidney recovery
AKD duration in days AKD severity described and compared by AKI stages Patients with AKD divided by subgroups regarding indication for CRRT (fluid overload, electrolyte disturbances, metabolic acidosis, uremia, oliguria/anuria) and CRRT dose (ml/kg/hour) CRRT free days during ICU Kidney recovery/stage of CKD/dialysis dependency
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start25 Sep 2025 (estimated)
- Primary completion25 Sep 2026 (estimated)
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Croatian Society for Organ Support
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vedran Premuzic, Croatian Society for Organ Support
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052617
- Sponsor's protocol ID
- 02/013AG
- Other IDs
- CSOS2025
- Acronym
- KARMA
- Status last verified
- Jul 2025
- First submitted
- 21 Jun 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Specific IPD including information like a participant's age, sex, treatment received, and specific outcomes will be shared
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric Observational Study Examining How Different CRRT Modalities, Dosing Strategies, and Timing Impact Kidney Recovery and the Development of Prolonged Kidney Dysfunction (Acute Kidney Disease) in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07052617
- Acronym / sponsor ID
- KARMA / 02/013AG
- Conditions
- Acute Kidney Disease, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Croatian Society for Organ SupportUniversity, hospital or other
- Study start
- 25 Sep 2025 (estimated)
- Primary completion
- 25 Sep 2026 (estimated)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
KARMA study is a hospital-based research study looking at how different ways of delivering kidney support therapy (CRRT) affect patients who are critically ill. In some cases, the kidneys may temporarily stop working in very sick patients, and machines are used to filter the blood. This study is exploring whether the way the investigators use these machines - how early to start, how much treatment to give, and what type to choose - makes a difference in how well the kidneys recover. By learning from many hospitals and hundreds of patients, KARMA hopes to improve treatment choices and help patients regain their kidney function faster.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- By analyzing the variation in therapeutic approaches across centers-including convection- and diffusion-based techniques, dose intensity, and initiation thresholds-KARMA study aims to identify best practices that promote renal recovery and reduce the transition to acute kidney disease. The study integrates clinical, biochemical, and outcome metrics to support a precision medicine framework in critical care nephrology and in critically ill patients with acute kidney injury.
Key inclusion criteria (2 listed)
- Acute kidney injury
- ICU administration
Key exclusion criteria (2 listed)
- Pre-existing CKD (GFR < 30 ml/min/1,73m2)
- Chronic dialysis-dependent end-stage renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuos renal replacement therapyDifferent modalities of CRRT: continuous veno-venous hemofiltration; continuous veno-venous hemodialysis and continuous veno-venous hemodiafiltration Different doses of CRRT: low effluent dose (<15 ml/kg/h); medium-low effluent dose (15-25 ml/kg/h); standard effluent dose (25-30 ml/kg/h); high effluent dose (>30 ml/kg/h | Device | – |
Primary outcome
Percentage of patients with AKD
Time frame: 90 days
Percentage of patients with AKD divided by subgroups regarding AKI etiology
1 secondary outcome
Durations and severity of AKD, free days of CRRT and kidney recovery
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: Yes. Specific IPD including information like a participant's age, sex, treatment received, and specific outcomes will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Disease and Acute Kidney Injury, run by Croatian Society for Organ Support.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with AKD (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.